Study to Assess Safety and Tolerability of AZD0530 in Combination With Carboplatin and Paclitaxel

Phase 1

Withdrawn

• Conditions: Cancer; Non Small Cell Lung Cancer; Epithelial Ovarian Cancer
• Interventions: Drug: AZD0530; Drug: Carboplatin; Drug: paclitaxel

• Registration Number: NCT01000896
• Lead Sponsor: AstraZeneca

Brief Summary

The primary purpose of this study is to explore the safety and tolerability of AZD0530 in combination with carboplatin and paclitaxel in Japanese patients with non small cell lung cancer and epithelial ovarian cancer.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-10-14
• Study First Submitted QC: 2009-10-22
• Study First Posted: 2009-10-23
• Study Start: 2010-01
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-03
• Last Update Posted: 2010-02-04
• Primary Completion: 2010-09
• Study Completion: 2011-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• Japanese patients with non small cell lung cancer or epithelial ovarian cancer
• Must be suitable for treatment with carboplatin and paclitaxel
• Relatively good overall health other than cancer

Exclusion Criteria

• Poor bone marrow function (not producing enough blood cells).
• Poor liver or kidney function.
• Patients unable to discontinue drugs known to be potent inhibitors or inducers of CYP3A4 within 2 weeks prior to registration

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AZD0530 + carboplatin and paclitaxel	AZD0530	AZD0530 in combination with carboplatin and paclitaxel
AZD0530 + carboplatin and paclitaxel	Carboplatin	AZD0530 in combination with carboplatin and paclitaxel
AZD0530 + carboplatin and paclitaxel	paclitaxel	AZD0530 in combination with carboplatin and paclitaxel

Primary Outcome Measures

Name	Time	Method
Assessment of adverse events (based on CTCAE version 3.0), laboratory values, vital sign measurements, general examination, HRCT, SpO2, ECG	Laboratory assessment prior to chemotherapy administration in all treatment cycles and on days 2, 8 and 15 in cycle 1. General exam, SpO2 and ECG prior to chemotherapy administration in all treatment cycles. HRCT scans performed days 21, 42, 70-98.

Secondary Outcome Measures

Name	Time	Method
Assessment of the pharmacokinetics of AZD0530 (Cssmax, Cssmin, tmax, AUCss0-24, CL/F), its N-desmethyl metabolite M594347 (Cssmax, Cssmin, tmax, AUCss0-24), and carboplatin / paclitaxel (Cmax, AUC, AUC0-t, t1/2, CL and Vss)	Schedule of PK assessment1. AZD0530/N-desmethyl metabolite M594347Cycle1-day21 -Cycle2-day2; 11point2. carboplatinCycle1-day1 ~ day2; 8 pointCycle2-day1 ~ day2; 8 point3. paclitaxelCycle1-day1 ~day2; 9 pointCycle2-day1 ~ day2; 9 point

Trial Locations

Locations (1)

Research Site; 🇯🇵 Fukuoka, Japan